LEADER RELIEF EYE
- Manufacturer
- CARDINAL HEALTH
- Effective date
- 2012-01-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:49:51
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Purpose
Tetrahydrozoline HCL 0.05% ...........................................................Redness Reliever
Zinc Sulfate 0.25%
.........................................................................Astringent
OTC - PURPOSE SECTION
Uses
- for the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.
- for the temporary relief of discomfort due to minor irritations of the eye
or to exposure to wind or sun.
WARNINGS SECTION
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not use: If this solution changes color or becomes cloudy or
if you are sensitive to any ingredient in this product.
OTC - WHEN USING SECTION
When using this product
- remove contact lenses before using
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
OTC - STOP USE SECTION
Stop use and ask a doctor if
- you feel eye pain
- changes in vision occur
- redness or irritation of eye gets worse or lasts more than 72
hours
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right
away.
INDICATIONS & USAGE SECTION
Directions
- instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
- Store at room temperature.
- Children under 6 years of age: Ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Edetate
Disodium, Purified Water, Sodium Chloride, Sodium Citrate
DOSAGE & ADMINISTRATION SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Enter section text here
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37205-138-05 | 2025-04-07 | C162847 | 48780-1 | 9d75b9d1-1ac4-f424-e053-dadaa90a57ce | Drug Facts |
| 37205-138-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1ac4-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37205-138-05 | ML - Milliliter | 37205-138 | 1fbe0a3a-7cd7-4f97-84a2-7577bda467b5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TETRAHYDROZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0YZT43HS7D | 2 | |
| ZINC SULFATE | ACTIVE INGREDIENT | 89DS0H96TB | 2 | |
| TETRAHYDROZOLINE | ACTIVE MOIETY | S9U025Y077 | 2 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 2 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- LEADER RELIEF EYE
- TETRAHYDROZOLINE HCL, ZINC SULFATE
- TETRAHYDROZOLINE HYDROCHLORIDE
- TETRAHYDROZOLINE
- ZINC SULFATE
- ZINC CATION
- BENZALKONIUM CHLORIDE
- BORIC ACID
- EDETATE DISODIUM
- WATER
- SODIUM CHLORIDE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37205-138 | 37205-138-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TETRAHYDROZOLINE HYDROCHLORIDE | 0YZT43HS7D | ACTIB |
| ZINC SULFATE | 89DS0H96TB | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BORIC ACID | BORIC ACID | R57ZHV85D4 | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY, METERED / NASAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRA-ARTICULAR | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 360 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | GEL / OPHTHALMIC | 0.5 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.86 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAOCULAR | 320 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LIQUID / NASAL | 0.2 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRASYNOVIAL | 0.9 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / INTRAVENOUS | 0.03 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / NASAL | 40.46 mg/100ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRA-ARTERIAL | 278 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.02 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LOTION / TOPICAL | 0.3 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / OPHTHALMIC | 2 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | JELLY / NASAL | NA | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LOTION / TOPICAL | 0.1 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ENDOTRACHEAL | 7.6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ENEMA / RECTAL | 0.7 %w/w | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION / OPHTHALMIC | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRALESIONAL | 13 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAMUSCULAR | 17 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / TOPICAL | 210 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBCUTANEOUS | 1486 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / AURICULAR (OTIC) | 0 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRAMUSCULAR | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / NASAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOAP / TOPICAL | 1.26 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTICULAR | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ENDOTRACHEAL | 46.76 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 672887d3-f1cb-443e-a0e0-86d261e0f2b7 | 2e5aa310-94e2-4ab2-bb44-2e029a5cbf69 | 2025-04-04 | Warnings | 2e5aa310-94e2-4ab2-bb44-2e029a5cbf69 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
